Medical Device CE Marking Services

Medical device CE marking is a legal requirement for placing a device on the market in the European Union. The CE mark shows that the device meets the General Safety and Performance Requirements (GSPRs) of EU MDR 2017/745. For most device classes, a Notified Body must certify the device before the manufacturer can affix the CE mark to the device and its packaging.

As medical device CE marking consultants, we guide you through the specific requirements for your device and support you until you obtain CE certification. We work across reusable devices, equipment, disposables, implants, drug–device combination products and home healthcare devices, in all risk classes.

We prepare CE marking technical documentation covering core sections such as risk analysis, clinical evaluation and usability, and submit it to the Notified Body of your choice. Manufacturers based outside the EU must also appoint an EU Authorised Representative before applying.

CE certification is how a manufacturer proves that a medical device is safe, performs as intended and meets the European regulations: EU MDR 2017/745 for medical devices, and EU IVDR 2017/746 for in vitro diagnostic devices.

The two terms are often used interchangeably, but there is a slight difference. CE marking is the mark itself, placed on the device and its packaging. CE certification is the whole process of meeting the regulatory requirements that allows you to apply that mark. You cannot legally place the CE mark on a medical device without completing that process.

Once a device carries the CE mark, it can be sold throughout the European Economic Area: the 27 EU member states plus Iceland, Liechtenstein and Norway. Switzerland and many countries in Asia, Africa, the Middle East and Latin America also accept the CE mark as a basis for registration.

Every medical device needs CE marking, but the route depends on its risk class. Most Class I devices allow the manufacturer to self-declare conformity. Class IIa, IIb and III devices, and Class I devices that are sterile, have a measuring function or are reusable surgical instruments, need a Notified Body to review the documentation before the CE mark can be applied. The process starts by identifying the device, its models, variants, accessories and consumables, and the standards that apply to it.

1. Device classification. Determine the device’s risk class (I, Is, Im, Ir, IIa, IIb or III) under the MDR classification rules. IVDs are classified A, B, C or D under the IVDR. The class decides the conformity assessment route and whether a Notified Body must review the device. See medical device classification.

2. Quality Management System (ISO 13485). Establish a QMS before applying for CE certification. ISO 13485 is the accepted standard and covers design control, risk management, supplier management, complaint handling and post-market surveillance.

3. Technical documentation. Compile the technical file: device description and intended purpose, design and manufacturing information, the GSPR checklist, risk management to ISO 14971, biological evaluation, sterilisation validation where relevant, performance data, and labelling and IFU.

4. Clinical evaluation. Show that the device is safe and performs as intended, using clinical investigations, published literature, or equivalence to a similar device. The results are documented in the Clinical Evaluation Report (CER). See EU MDR clinical evaluation.

5. Notified Body assessment. Where required, the Notified Body reviews the technical documentation, the QMS and the clinical evidence, and audits the manufacturing site, before issuing the CE certificate.

6. Declaration of Conformity, EUDAMED and CE mark. The manufacturer signs the EU Declaration of Conformity, completes EUDAMED registration and UDI assignment, and affixes the CE mark. The device can then be placed on the EEA market.

For a stage-by-stage view of these steps with typical timelines, see our CE marking process and timeline.

Notified Bodies are independent organisations designated by EU member states to assess medical devices and IVDs. For every device except the lowest-risk Class I devices, the manufacturer must obtain a CE certificate from a Notified Body before selling in the EU. The Notified Body reviews:

• the technical documentation
• the clinical evidence
• the quality management system
• risk management activities

It also audits the manufacturer’s facility to confirm that the QMS works in practice. Only a limited number of Notified Bodies are designated under the MDR and IVDR, and not every one covers every device type. Choosing the right body early and submitting well-prepared documentation are the best ways to avoid long queues. See the current list of MDR and IVDR Notified Bodies.

The Medical Device Regulation (EU) 2017/745 replaced the old Medical Device Directive 93/42/EEC. It entered into force on 25 May 2017 and has applied since 26 May 2021. As a regulation, it applies directly in all EU member states and the EEA.

The standards are considerably higher than under the MDD. Claims of equivalence need full substantiation, clinical data requirements are more rigorous, post-market surveillance must be active and continuous, and technical documentation is reviewed throughout the device’s life, not just once at submission.

The core requirements a manufacturer must meet under the MDR include:

• device classification and the right conformity assessment procedure
• a Person Responsible for Regulatory Compliance (PRRC)
• a quality and risk management system
• a complete technical documentation file
• clinical evaluation
• post-market surveillance, vigilance and market surveillance
• an EU Authorised Representative, if you are based outside the EU
• a Notified Body certificate, where your class requires it
• an EU Declaration of Conformity
• EUDAMED registration and Unique Device Identification (UDI)
• the CE mark on the device

For manufacturers transitioning legacy MDD devices or entering the EU market for the first time, understanding these requirements early saves significant time and cost.

Medical devices and IVDs both need CE marking, but they follow different regulations.

Medical devices: EU MDR 2017/745. Manufacturers must prepare a clinical evaluation plan and report, a risk management file to ISO 14971, a post-market surveillance plan and report, a Periodic Safety Update Report (PSUR) where required, EUDAMED and UDI data, and a complete technical documentation file, all supported by an ISO 13485 quality management system.

IVDs: EU IVDR 2017/746. The IVDR covers test kits, reagents and laboratory instruments. It introduced a risk-based classification (Class A, B, C and D), which greatly increased the number of IVDs that need Notified Body review. Manufacturers must demonstrate scientific validity, analytical performance and clinical performance, and run post-market performance follow-up (PMPF). Requirements are most demanding for Class C and D devices.

For the full IVD route, see IVD CE marking.

CE marking is mandatory to sell medical devices in the European Economic Area, a market of about 450 million people. Because many countries outside Europe also accept the CE mark for registration, manufacturers worldwide pursue CE certification even when Europe is not their first market.

Large manufacturers usually have dedicated regulatory affairs teams. Small and medium-sized companies often do not, and are uncertain what documents are required and how much the process will cost. Preparing MDR technical documentation is a sizeable task without previous experience, which is where an experienced CE marking partner makes the difference.

CE marking under the MDR and IVDR takes time, detailed documentation and a clear understanding of the regulations. Manufacturers in the UK, USA, India and elsewhere run into the same problems:

• Not enough clinical data. The MDR requires evidence from clinical studies, published literature or post-market surveillance. For newer devices without a long history of use, building that evidence takes considerable work.
• Complex documentation. Technical files must cover design, manufacturing, risk management, labelling and clinical evaluation, in the format Notified Bodies expect. Smaller companies often lack the dedicated resources.
• Choosing the right Notified Body. Not every Notified Body covers every device type, and the limited number designated under the MDR has lengthened waiting times for review slots.
• Long review timelines. Reviews can take several months even after a complete submission, and any gaps or questions add further delay.
• Transitioning from the MDD. Legacy devices need rebuilt technical documentation, stronger clinical evidence and more demanding post-market surveillance, and equivalence claims need stronger justification.
• Keeping the QMS and certificates current. Certification is not a one-off. The quality system, technical file and clinical evaluation must be maintained and updated to keep the CE certificate valid.

The cost of CE marking depends on your device class, the complexity of your technical documentation, Notified Body involvement and how much support your team needs. Class I self-declared projects cost less, because no Notified Body fee applies. For Class IIa, IIb and III devices, budget for the consultancy fee plus the Notified Body assessment fee, which varies by body and device type.

I3CGlobal’s CE certification consultancy starts from €9,000 for online engagements, covering gap analysis, technical documentation support, clinical evaluation assistance and Notified Body coordination. For Class IIb and III devices, the process typically takes 12–16 months, depending on device complexity, your team’s readiness and Notified Body availability.

• MDR CE certification cost
• IVDR CE certification cost
• MDR CE marking cost calculator
• CE marking process and timeline

Under today’s MDR rules, manufacturers face extensive questions from Notified Bodies, both during certification and in keeping CE certificates valid. Our CE marking consultants provide the expert manpower and guidance to handle this at every stage. That covers initial classification and technical documentation, clinical evaluation, Notified Body submission and responses, and ongoing file updates. See also our CE marking approval process.

Why manufacturers choose I3CGlobal

Since 2010, we have helped over 800 manufacturers across 40 countries achieve compliance under EU MDR and IVDR, from Class I consumables to Class III implants and Class D IVDs. Our consultants have direct experience of Notified Body submissions, clinical evaluation writing, ISO 13485 implementation and EUDAMED registration. Every engagement is handled by qualified regulatory professionals, with no subcontracting and no templates handed over without support.

• UK manufacturers: CE and UKCA compliance managed together from our London office, including an EU Authorised Representative and EUDAMED registration.
• European manufacturers: hands-on support from our teams in Germany and Portugal, in your time zone.
• USA and Canada: support from our Chicago and Charlotte offices to bridge FDA and EU MDR requirements without duplicating work.
• India and Asia-Pacific: technical documentation, clinical evaluation, ISO 13485 and EU Representative services from our Bangalore, Delhi, Penang and Seoul teams.

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